Intraoperative Pain ControlNCT04095325
Transversus Abdominis Plane Block Versus Erector Spina Plane Block
A study testing Ultrasound guided erector spinae block in people with Intraoperative Pain Control, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Intraoperative Pain Control
- What is being tested?
- Ultrasound guided erector spinae block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II,
- undergo elective lower abdominal surgery
- 2-6 years
Who cannot join
- Psychiatric patients,
- weight> 40 kg,
- those with cardiac-pulmonary-neurological disease,
- those with bleeding disorders,
- infection or wound scarring at the injection site,
- known allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
ufuk kuyrukluyıldız contact
About this study
Official title: Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spina Plane Block in Pediatric Lower Abdominal Surgery
Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.
- Conditions
- Intraoperative Pain Control
- Being tested
- Ultrasound guided erector spinae block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided erector spinae blockDevice
Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane block | Active comparator | Group 1 (n: 50): those who underwent TAP block after induction of propofol atropine and maintained with only 1 mg / kg / h propofol in anesthesia maintenance Receives: Device: Ultrasound guided erector spinae block |
| erector spinae block | Active comparator | Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance Receives: Device: Ultrasound guided erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
effectiveness of erector spinae block on intraoperative anesthesia
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intraoperative Pain ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095325
- Sponsor's protocol ID
- EBYU ESP
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
PubMed 30886130Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.
PubMed 20857679Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.
PubMed 29341379Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
PubMed 23252578Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
PubMed 27366540
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spina Plane Block in Pediatric Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04095325
- Acronym / sponsor ID
- EBYU ESP
- Conditions
- Intraoperative Pain Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane block | Active comparator | Device: Ultrasound guided erector spinae blockGroup 1 (n: 50): those who underwent TAP block after induction of propofol atropine and maintained with only 1 mg / kg / h propofol in anesthesia maintenance |
| erector spinae block | Active comparator | Device: Ultrasound guided erector spinae blockGroup 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I-II,
- undergo elective lower abdominal surgery
- 2-6 years
Key exclusion criteria (6 listed)
- Psychiatric patients,
- weight> 40 kg,
- those with cardiac-pulmonary-neurological disease,
- those with bleeding disorders,
- infection or wound scarring at the injection site,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided erector spinae blockGroup 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance | Device | erector spinae block, transversus abdominis plane block |
Primary outcome
Visual analogue scale
Time frame: 4 months
effectiveness of erector spinae block on intraoperative anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Results publication: PubMed 30886130Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
- Results publication: PubMed 20857679Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Results publication: PubMed 29341379Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.
- Results publication: PubMed 23252578Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
- Results publication: PubMed 27366540Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ufuk kuyrukluyıldız contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided erector spinae block in people with Intraoperative Pain Control, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke küpeli (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095325, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.